InjuryKWS
CUSTOM PROXIMAL HUMERUS
Received Jun 29, 2026 · Event occurred Feb 2, 2026
Report 3014833750-2026-00021 · MDR key 25654071
Device
Product problems
- Detachment of Device or Device Component
- Device Dislodged or Dislocated
Patient
NA · Unknown
- Joint Dislocation
Narrative
Description of Event or Problem
A CUSTOM PROXIMAL HUMERUS RECONSTRUCTION IN CONJUNCTION WITH A REVERSE TOTAL SHOULDER REPLACEMENT HAD TO BE REVISED DUE TO POLYETHYLENE LINER DISASSOCIATION. THE PATIENT EXPERIENCED MINOR TRAUMA PLACING WEIGHT ONTO THE OPERATIVE ARM WHEN DISASSOCIATION OCCURRED.
Additional Manufacturer Narrative
THE INVESTIGATION HAD A DIMENSIONAL MEASUREMENT WHICH PROHIBITED FULL SEATING OF THE POLYETHYLENE LINER. CONTAINMENT HAS BEEN ADDRESSED AND NO OTHER DEVICES ARE IMPACTED.